Study of Bosutinib in Japanese Adult Patients With Newly Diagnosed Chronic Phase Chronic Myelogenous Leukemia
NCT03128411
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Adult Trials: 18+ Years
- Diagnosis of CP CML of ≤6 months (from initial diagnosis); Diagnosis of CP CML with molecular confirmation by detection of BCR-ABL rearrangement at screening (cytogenetic assessment for Ph is not required for enrollment; however, patients with known Ph- CML prior to registration are not eligible for this study)
- Age ≥20 years
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1
- Adequate Liver and Renal Function
- Any prior medical treatment for CML, including TKIs, with the exception of hydroxyurea
treatment, which is permitted for up to 6 months prior to registration
- Any past or current CNS involvement, including leptomeningeal leukemia
- Extramedullary disease only
- Major surgery or radiotherapy within 14 days prior to registration
- History of clinically significant or uncontrolled cardiac disease
- Patients with active, uncontrolled bacterial, fungal, or viral infection
- Recent or ongoing clinically significant GI disorder
- History of another malignancy within 5 years prior to registration
- Uncontrolled hypomagnesemia or uncorrected hypokalemia due to potential effects on the
QT interval
- Known prior or suspected severe hypersensitivity to study drugs or any component in
their formulations
- Participation in other studies involving investigational drug(s) within 30 days or 5
half-lives of investigational product, whichever is longer, prior to registration
and/or during study participation
- Other severe acute or chronic medical or psychiatric condition, including recent or
active suicidal ideation or behavior, or laboratory abnormality that may increase the
risk associated with study participation or interfere with the interpretation of study
results
- Investigational site staff members directly involved in the conduct of the study and
their family members, or Pfizer employees, including their family members, directly
involved in the conduct of the study
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| Descriptive Information | |||||||
|---|---|---|---|---|---|---|---|
| Brief Title ICMJE | Study of Bosutinib in Japanese Adult Patients With Newly Diagnosed Chronic Phase Chronic Myelogenous Leukemia | ||||||
| Official Title ICMJE | A PHASE 2, OPEN-LABEL, SINGLE-ARM STUDY TO EVALUATE EFFICACY AND SAFETY OF BOSUTINIB MONOTHERAPY IN JAPANESE ADULT PATIENTS WITH NEWLY DIAGNOSED CHRONIC PHASE CHRONIC MYELOGENOUS LEUKEMIA | ||||||
| Brief Summary | Phase 2, single-arm, open-label trial. Patients will receive bosutinib for the duration of the study. | ||||||
| Detailed Description | The study will be open for enrollment until the planned number of approximately 60 Philadelphia Chromosome Positive (Ph+) patients have been registered. All patients will be treated and/or followed for up to approximately 3 years (144 weeks) after registration of the last patient or until study termination. Patients who discontinue study therapy early due to disease progression or intolerance to study medication will continue to be followed yearly for survival for up to approximately 3 years (144 weeks) after registration of the last patient or until study termination. | ||||||
| Study Type ICMJE | Interventional | ||||||
| Study Phase ICMJE | Phase 2 | ||||||
| Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment | ||||||
| Condition ICMJE | Leukemia, Chronic Myelogenous | ||||||
| Intervention ICMJE | Drug: Bosutinib
All patinets will receive bosutinib at a starting dose of 400 mg QD. | ||||||
| Study Arms ICMJE | Experimental: Bosutinib
Bosutinib monotherapy; All patients will receive bosutinib at a starting dose of 400 mg QD. The dose of bosutinib may be escalated (up to a maximum of 600 mg QD) for unsatisfactory response or reduced for toxicity. Intervention: Drug: Bosutinib | ||||||
| Publications * | Hino M, Matsumura I, Fujisawa S, Ishizawa K, Ono T, Sakaida E, Sekiguchi N, Tanetsugu Y, Fukuhara K, Ohkura M, Koide Y, Takahashi N. Phase 2 study of bosutinib in Japanese patients with newly diagnosed chronic phase chronic myeloid leukemia. Int J Hematol. 2020 Jul;112(1):24-32. doi: 10.1007/s12185-020-02878-x. Epub 2020 Apr 11. | ||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | |||||||
| Recruitment Information | |||||||
| Recruitment Status ICMJE | Active, not recruiting | ||||||
| Actual Enrollment ICMJE | 64 | ||||||
| Original Estimated Enrollment ICMJE | 60 | ||||||
| Estimated Study Completion Date ICMJE | March 5, 2021 | ||||||
| Actual Primary Completion Date | March 12, 2019 (Final data collection date for primary outcome measure) | ||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
| ||||||
| Sex/Gender ICMJE |
| ||||||
| Ages ICMJE | 20 Years and older (Adult, Older Adult) | ||||||
| Accepts Healthy Volunteers ICMJE | No | ||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||
| Listed Location Countries ICMJE | Japan | ||||||
| Removed Location Countries | |||||||
| Administrative Information | |||||||
| NCT Number ICMJE | NCT03128411 | ||||||
| Other Study ID Numbers ICMJE | B1871048 | ||||||
| Has Data Monitoring Committee | No | ||||||
| U.S. FDA-regulated Product |
| ||||||
| IPD Sharing Statement ICMJE |
| ||||||
| Responsible Party | Pfizer | ||||||
| Study Sponsor ICMJE | Pfizer | ||||||
| Collaborators ICMJE | Not Provided | ||||||
| Investigators ICMJE |
| ||||||
| PRS Account | Pfizer | ||||||
| Verification Date | November 2020 | ||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP | |||||||